The Effects of Antihistamines on Pre-Pulse Inhibition (PPI)

This study has been completed.
Sponsor:
Collaborator:
Wallace Foundation
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01537471
First received: February 1, 2012
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

The purpose of the investigators research is to test whether problems people have with processing their senses (feeling overwhelmed, distracted or upset by sounds and other stimuli) can be lessened by meclizine, a drug found in many over the counter antihistamines, which are medicines used for things like allergies, sleep problems, or the common cold.


Condition Intervention Phase
Healthy
Drug: Placebo
Drug: Meclizine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effects of Meclizine on Pre-Pulse Inhibition

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in PPI [ Time Frame: Screening Day 1, Days 2-4 ] [ Designated as safety issue: No ]
    The primary outcome will measure change in subjects' PPI depending on whether they were given meclizine during the study. Prepulse inhibition (PPI) of the startle reflex by a weak pre-pulse will be assessed during each laboratory session. It is measured using electromyographic (EMG; i.e., for assessing eye blink magnitude) responses.


Secondary Outcome Measures:
  • Sedation [ Time Frame: Day 2, Day 3, & Day 4 ] [ Designated as safety issue: Yes ]
    A Baseline sedation level at the beginning of each visit will be collected. Then study drug (meclizine/placebo) will be given and a sedation level will be collected at 20 minutes and 40 minutes post drug as well as during the PPI experiment pre & post. The Sedation scale will be used (a modified version of the SAM scale).


Enrollment: 117
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo
A counterbalanced design will be used with each male subject receiving placebo and each of the anti-histamine low (12.5 mg) and high (25 mg) doses in a counterbalanced order to keep order of administration from being confounded with dose level. On one of three visits, a subject will receive placebo. The subject, study coordinator, co-investigator and outcomes assessor will remain blinded to what they received until data analysis is completed.
Drug: Placebo
Placebo
Other Name: Sugar Pill
Experimental: Meclizine
A counterbalanced design will be used with each male subject receiving placebo and each of the anti-histamine low (12.5 mg) and high (25 mg) doses in a counterbalanced order to keep order of administration from being confounded with dose level. By the time they finish, they will have all received placebo, 12.5mg meclizine and 25mg meclizine. The subject, study coordinator, co-investigator and outcomes assessor will remain blinded to what they received until data analysis is completed.
Drug: Meclizine
Meclizine 12.5 mg
Other Name: Antivert, Dramamine II, Bonine, Medivert
Drug: Meclizine
Meclizine 25 mg
Other Name: Antivert, Dramamine II, Bonine, Medivert

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-40 males or females
  • Startle response >0.5
  • PPI < 32
  • CO level <8ppm

Exclusion Criteria:

  • Tobacco or nicotine use within 2 weeks of screening
  • Current or history of a neurological disorder of neurological event
  • Negative response to antihistamine use in past
  • ECT treatment in the past 6 months
  • Current or past history of manic or hypomanic episodes (SCID-I)
  • Current or history of psychotic disorder
  • Current alcohol or substance abuse/dependence
  • Positive urine drug test
  • CO level of >8ppm
  • Startle <0.5 & overall PPI >32 (assessed during study)
  • Significant hearing problem
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537471

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Wallace Foundation
Investigators
Principal Investigator: Mark Z Rosenthal, PhD Duke University
Principal Investigator: Ed Levin, MD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01537471     History of Changes
Other Study ID Numbers: Pro00028299
Study First Received: February 1, 2012
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
PPI
Meclizine
Startle
Sensory processing
antihistamines

Additional relevant MeSH terms:
Histamine Antagonists
Histamine H1 Antagonists
Meclizine
Anti-Allergic Agents
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Histamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014